Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391749
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-25
Brief Title:
Clinical Validation of an MCED Test in Symptomatic Populations K-ACCELERATE
Sponsor:
Gene Solutions
Organization:
Gene Solutions
Study Overview
Official Title:
K-ACCELERATE A Multi-center Prospective Trial to Evaluate Clinical Utility of Multi Cancer Early Detection Test as a Triage Test for Symptomatic Participants
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
K-ACCELERATE
Brief Summary:
To evaluate the diagnostic performance of blood-based SPOT-MAS test in symptomatic individuals the investigators sought to launch a prospective multicenter study named K-ACCELERATE The study aims to recruit 1000 participants who develop symptoms and signs specific to the top five common cancer types including breast colorectal gastric liver and lung cancer
Primary objective Evaluate the performance of the SPOT-MAS test in detecting cancer in symptomatic populations
Secondary objectives Evaluate the feasibility of incorporating SPOT-MAS as a triage test into primary care to increase the detection rates of malignant cancer while minimizing unnecessary referrals to invasive procedures
Primary objective Evaluate the performance of the SPOT-MAS test in detecting cancer in symptomatic populations
Secondary objectives Evaluate the feasibility of incorporating SPOT-MAS as a triage test into primary care to increase the detection rates of malignant cancer while minimizing unnecessary referrals to invasive procedures
Detailed Description:
Participants are recruited and referred to one of the five diagnosis pathways according to the participants symptoms and signs listed
Before undertaking imaging tests 10 ml of blood is collected in Streck tube for SPOT-MAS test
Participants undertake low-resolution imaging LRI tests matching with participants referral diagnosis pathway Imaging test results are returned within the same day
If participants get negative results from both SPOT-MAS and LRI participants will receive treatment for the symptoms based on the standard treatment scheme at hospitals and be followed up for 12 months to confirm their cancer-free status
- If participants get a positive result from either SPOT-MAS or LRI participants will be referred to high-resolution imaging tests HRI or tissue biopsy to confirm the presence of tumor
For those with positive results confirming invasive tumors by HRI or tissue biopsy patients will undergo treatment The investigators do not provide financial support for their treatment
For those with no invasive lesions but having positive SPOT-MAS results participants will be advised to re-take the SPOT-MAS test after 6 months
If the 2nd SPOT-MAS test results return positive participants will be advised to perform whole body CT scan If participants scanning results return positive participants will undergo tissue biopsy and treatment
If the 2nd SPOT-MAS or whole body CT scan is negative participants will be followed-up for an additional 6 months by surveying to confirm the cancer-free status
The enrolment is anticipated to last for approximately 6 months
Before undertaking imaging tests 10 ml of blood is collected in Streck tube for SPOT-MAS test
Participants undertake low-resolution imaging LRI tests matching with participants referral diagnosis pathway Imaging test results are returned within the same day
If participants get negative results from both SPOT-MAS and LRI participants will receive treatment for the symptoms based on the standard treatment scheme at hospitals and be followed up for 12 months to confirm their cancer-free status
- If participants get a positive result from either SPOT-MAS or LRI participants will be referred to high-resolution imaging tests HRI or tissue biopsy to confirm the presence of tumor
For those with positive results confirming invasive tumors by HRI or tissue biopsy patients will undergo treatment The investigators do not provide financial support for their treatment
For those with no invasive lesions but having positive SPOT-MAS results participants will be advised to re-take the SPOT-MAS test after 6 months
If the 2nd SPOT-MAS test results return positive participants will be advised to perform whole body CT scan If participants scanning results return positive participants will undergo tissue biopsy and treatment
If the 2nd SPOT-MAS or whole body CT scan is negative participants will be followed-up for an additional 6 months by surveying to confirm the cancer-free status
The enrolment is anticipated to last for approximately 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None